The FDA clearance of the ROBODOC system


Even though the Integrated Surgical Systems Inc. developed the Robodoc and sold app. 50 units in Europe and Asia, due to the continuing liquidity problems it could not live long enough to vitnes the FDA approval of the robot. (See previous post.)
The ROBODOC, a Curexo Tech, Inc. was founded in 2002 to marketize and profit from the Robodoc system. In August 2008 the system finally received a 510(k) clearance from FDA.
This 510(k) FDA clearance is an important milestone because it opens up doors to other manufacturers of similar (automated) robotic surgery systems. The process of applying for FDA clearance is easier for other robotic systems if they can prove that they are sufficiently similar to an existing product (i.e., ROBODOC).
"The newly cleared system delivers a precise, repeatable surgical technique to prepare the joint for hip replacement procedures. The process allows the surgeon to select an ideal implant from multiple implant manufacturers after reviewing a detailed CT scan of the patient’s joint. Utilizing the proprietary system software, surgeons for the first time can now preview the surgical outcome before beginning the actual operation.
This system includes two components; ORTHODOC®, a computer workstation equipped with proprietary software for 3-D preoperative surgical planning, and the ROBODOC® Surgical Assistant, a computer-controlled surgical robot utilized for precise cavity and surface preparation for hip and knee replacement surgeries. The ROBODOC System, previously marketed by Integrated Surgical Systems (ISS), made medical history in 1992 as the first robot assisting in a human Total Hip Arthroplasty (THA).
The robotic assistant has been used in over 24,000 joint replacement procedures worldwide and is shown to be less traumatic for patients and more precise than manual preparation techniques. In Total Hip surgery applications the ROBODOC System executes exact bone cutting and precise implant placement to reduce surgical fractures and complications and minimize human error."

Update: TV coverage of the approval, and the press conference (video) about it.

Update2: ROBODOC starts to sell large in Japan

Source: Robodoc.com

Comments

Depuy Pinnacle Lawsuit said…
This seems like a very nice innovation. A metal-on-metal replacement device has also been on the market to suit the “young actives’ (those aging from 55 or younger with an active lifestyle) but unfortunately some were subjected to recall such as DePuy Pinnacle Recall because they are found to be more destructive than beneficial.
July 22, 2011 at 4:41 PM
Unknown said…
As time goes by, technology advances which sometimes provide good and bad effects to human being. Hence, metal on metal hip replacement devices change in a person's life though some evidence mount that these hip implants has been causing side effects that thousands of patients was suffering. This is proved that it has a high failure rate. Updates available here.
January 28, 2013 at 9:01 AM
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